# FDA 483 - Appco Pharma LLC - August 29, 2023

Source: https://www.globalkeysolutions.net/records/483/appco-pharma-llc/59a273fd-4c91-444e-9ad5-c199131868cc

> FDA 483 for Appco Pharma LLC on August 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Appco Pharma LLC
- Inspection Date: 2023-08-29
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Appco Pharma LLC in Piscataway, NJ, a manufacturer of non-sterile drug products, revealed significant deficiencies across three observations. The firm failed to maintain adequate humidity control for drug product packaging and storage, did not follow established warehousing procedures for material identification and storage, and lacked proper training for Quality Control laboratory personnel, leading to repeated out-of-specification results.

## Related Documents

- [483 - 2018-11-06](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/77127765-6933-4bf8-8395-40e6347a7f9b)
- [483 - 2021-07-30](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/1b2e5e98-ff75-4931-b993-325988d4ad69)
- [483 - 2022-08-19](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/383ce386-ac41-4477-8ec2-01baa182d21d)
- [483 - 2024-03-11](https://www.globalkeysolutions.net/records/483/appco-pharma-llc/1b46e495-7d63-4606-8eea-c099ef180959)

## Related Officers

- [Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/alice-s-tsao/b6d72ceb-de7c-413d-b104-cac3b075c170)
- [Ankur C. Patel](https://www.globalkeysolutions.net/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

Company: https://www.globalkeysolutions.net/companies/appco-pharma-llc/b4a77ba5-0e8a-47ae-94c2-951f5a0b2100

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248